DEVICE: Pure-Vu (05060513700052)
Device Identifier (DI) Information
Pure-Vu
PV-OS-001
In Commercial Distribution
PV-OS-001
MOTUS GI MEDICAL TECHNOLOGIES LTD
PV-OS-001
In Commercial Distribution
PV-OS-001
MOTUS GI MEDICAL TECHNOLOGIES LTD
(1) Oversleeve individually packaged
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
12301 | Colonic lavage system, powered-flow |
A device assembly designed for automated or semi-automated irrigation, washing, and evacuation of debris from the colon. It typically consists of a mains electricity (AC-powered) electromechanical unit that includes a pump for infusion of non-medicated fluids (e.g., saline), an extractor (frequently using vacuum), and controls for the temperature and the rate of infusion (e.g., using a nozzle) and withdrawal of the liquid; the system is coupled to dedicated handpieces and/or to disposable catheters introduced through the rectum. It is intended to be used by a healthcare provider in a clinical setting to remove damaged tissue and/or debris (e.g., faeces, foreign objects).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FDF | Colonoscope And Accessories, Flexible/Rigid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K160015 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -10 and 60 Degrees Celsius |
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity |
Handling Environment Temperature: between 10 and 30 Degrees Celsius |
Handling Environment Humidity: between 10 and 80 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 0 and 81 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
d564038f-ba84-4087-a49d-c18bf894e5be
July 06, 2018
3
January 03, 2017
July 06, 2018
3
January 03, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
888-438-9996
customer@motusgi.com
customer@motusgi.com